ESG Reporting in Pharmaceuticals: CSRD, Access to Medicine, and Clinical Trial Ethics

ESG reporting in the pharmaceutical sector is distinctive because the most material social issues are intrinsic to the industry's core business model. Access to medicine — whether a company's drugs reach the patients who need them at affordable prices — is not a peripheral CSR consideration; it is the central governance question facing the sector. At the same time, pharmaceutical manufacturing carries specific environmental risks — from API (active pharmaceutical ingredient) discharge into waterways to high-energy fermentation and synthesis processes — that require dedicated disclosure.

Access to Medicine: The Sector's Defining Social Issue

The Access to Medicine Index, published biennially, benchmarks the world's largest pharmaceutical companies on their efforts to improve access to medicine in low- and middle-income countries. Under ESRS S4 (Consumers and End-Users), pharmaceutical companies in scope for CSRD must disclose their policies and practices related to the accessibility and affordability of their products. This includes differential pricing strategies, voluntary licensing arrangements, technology transfer to generic manufacturers, and participation in pooled procurement mechanisms such as those operated by the Global Fund and GAVI.

Clinical Trial Ethics and Informed Consent

The conduct of clinical trials — particularly those conducted in low- and middle-income countries — is a material governance risk for pharmaceutical companies. Allegations of inadequate informed consent, exploitation of vulnerable populations, and post-trial access commitments have generated significant reputational damage for major pharma companies. Under ESRS G1 (Business Conduct) and ESRS S4, companies must disclose their policies for ethical conduct in clinical research, including alignment with the Declaration of Helsinki and ICH E6 Good Clinical Practice guidelines.

Pharmaceutical Pollution and Environmental Reporting

Pharmaceutical residues in waterways — from both manufacturing discharge and patient excretion — contribute to antimicrobial resistance (AMR), one of the most significant public health risks of the coming decades. The AMR Industry Alliance has developed manufacturing discharge standards that leading pharmaceutical companies have committed to. Under ESRS E2 (Pollution), companies must disclose emissions to water from manufacturing sites, policies for controlling pharmaceutical pollution, and alignment with responsible manufacturing standards. CDP Water Security reporting is widely used alongside ESRS E2 in this sector.

Key ESG KPIs for Pharmaceutical Reporting

• Access to medicine programmes — number of products covered by differential pricing, voluntary licensing, or donation programmes (ESRS S4)
• Pharmaceutical discharge to water — API concentration in manufacturing effluent against AMR Industry Alliance standards (ESRS E2)
• R&D investment in neglected tropical diseases — percentage of total R&D budget (ESRS S4)
• Clinical trial ethical compliance — percentage of trials with independent ethics committee approval (ESRS G1)
• Scope 1 and 2 GHG emissions — from fermentation, synthesis, and site energy use (ESRS E1)
• Hazardous waste generated and treatment method — from synthesis processes and solvent use (ESRS E5)
• Patient data breach incidents — compliance with GDPR in clinical and commercial data management (ESRS G1)

Navigating the CSRD Timeline for Pharma

Major pharmaceutical companies — Roche, Pfizer, Novartis, Sanofi, and their European peers — were among the first wave of CSRD reporters from financial year 2024. Mid-sized pharma companies reporting from FY2025 face the additional challenge of applying ESRS standards without the dedicated sustainability reporting teams that large multinationals have built. For these organisations, the double materiality assessment — which must determine whether access to medicine, clinical ethics, and pollution are material issues for their specific business — is the essential starting point. Enable Good supports pharma companies in designing materiality processes that meet ESRS standards while remaining proportionate to company size.